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The use of both levamisole & Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection
Study design: Randomized controlled trial, randomization by closed envelope technique Informed consent will be written for each patient of either group
At the beginning of the study all patients will have the following investigations done: CBC with differential, ESR, PCR for COVID 19, D dimer and CT chest and confirmed cases will included in the study
Pregnant and lactating women together with children with other comorbidities will be excluded from the study
Study groups:
Duration of the study is 4 weeks
Both groups with persistent COVID 19 symptoms that require hospitalization
Group 1: 30 patients with confirmed COVID19 infection and sharing clinical features like fever, malaise, sore throat, runny nose, persistent cough &dyspnea, requiring hospitalization
Group 2: control group: 30 patients
Treatment endpoint • Cure of patients: Improvement of symptoms Laboratory findings ESR and total leucocytic count returning to normal PCR negative Radiological improvement
• Worsening of symptoms or fatalities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proposed treatment group | Active Comparator | Levamisole and isoprinosine |
|
| Control group | Active Comparator | hydroxychloroquine and azithromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levamisole and isoprinosine | Drug | oral tablets levamisole 50 mg 3 times daily every other day for 2 weeks Isoprinosine oral tablets 1 g 4 times daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID 19 induced fever in both groups | Improvement of fever in degrees celsius | 4 weeks |
| COVID 19 induced dyspnea in both groups | improvement of dyspnea by normalization of respiratory rate | 4 weeks |
| COVID 19 viral load in both groups | PCR of COVID 19 changes from positive to negative | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| laboratory clearance in both groups: CRP in mg/dL | CRP in mg/dL | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagar El Sayed, MD | Contact | 0223682030 | hgr_ntr@yahoo.com | |
| Mohamed El Darouti, Professor | Contact | 0223682030 |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed El Darouti, Professor | Cairo University | Principal Investigator |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D007978 | Levamisole |
| D007542 | Inosine Pranobex |
| D017963 | Azithromycin |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| Azithromycin and hydroxychloroquine | Drug | oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily |
|
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |